510(k) K221003

Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA by Covidien — Product Code GDW

K221003 is an FDA 510(k) premarket notification submitted by Covidien for the device "Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA". The FDA issued a decision of Substantially Equivalent on September 30, 2022. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Covidien has at least 10 other 510(k) clearances on record.